WO2023205257A1 - Systèmes de détection de fil-guide à fibre optique - Google Patents

Systèmes de détection de fil-guide à fibre optique Download PDF

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Publication number
WO2023205257A1
WO2023205257A1 PCT/US2023/019130 US2023019130W WO2023205257A1 WO 2023205257 A1 WO2023205257 A1 WO 2023205257A1 US 2023019130 W US2023019130 W US 2023019130W WO 2023205257 A1 WO2023205257 A1 WO 2023205257A1
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WIPO (PCT)
Prior art keywords
elongate probe
along
optical fiber
guidewire
distal tip
Prior art date
Application number
PCT/US2023/019130
Other languages
English (en)
Inventor
Anthony K. Misener
Steffan SOWARDS
William Robert MCLAUGHLIN
Original Assignee
Bard Access Systems, Inc.
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Filing date
Publication date
Application filed by Bard Access Systems, Inc. filed Critical Bard Access Systems, Inc.
Publication of WO2023205257A1 publication Critical patent/WO2023205257A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A61B5/068—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe using impedance sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/339—Displays specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • A61B2562/0266—Optical strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types
    • A61B2562/063—Arrangements of multiple sensors of different types in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types
    • A61B2562/066—Arrangements of multiple sensors of different types in a matrix array

Definitions

  • Elongate medical devices configured for insertion with a patient may be utilized to perform a myriad of treatments and diagnoses.
  • An elongate medical device may be a catheter that is advanced along a vasculature of the patient to deliver medication to the patient at a desired location of the vasculature, such as the superior vena cava, for example.
  • a desired location of the vasculature such as the superior vena cava, for example.
  • proper placement of the catheter along the vasculature may be important and improper placement may define a risk to the patient.
  • Electromagnetic tracking systems have also been utilized to track medical devices, such as devices involving stylets. Electromagnetic tracking systems eliminate radiation exposure associated with fluoroscopic methods and do not require line of site. However, electromagnetic tracking systems generally require multiple component to generate a magnetic field, sense the magnetic field, and interpret magnetic signals. Furthermore, electromagnetic tracking systems are subject to electromagnetic field interference caused by other electronic devices close by. Further still, electromagnetic tracking systems are subject to signal drop out, depend on an external sensor, and are defined to a limited depth range.
  • elongate medical device cause trauma or injury to a patient during insertion into the patient body or advancement along a lumen with the patient body.
  • Some medical devices include electrical conducting members extending along the length of the medical device.
  • One such system is disclosed in U.S. Pat. No. 8,801,693, titled “Bioimpedance-Assisted Placement of a Medical Device” filed October 27, 2011, which is incorporated herein by reference in its entirety.
  • Some elongate devices may include fiber optic capability.
  • the medical device includes an elongate probe configured for insertion into a patient body, where the elongate probe defines a proximal end and a curved distal tip at a distal end.
  • the device further includes an optical fiber extending along the elongate probe from the proximal end to the distal end, where the optical fiber includes one or more core fibers extending along a longitudinal length of the optical fiber.
  • Each of the one or more core fibers includes a plurality of sensors distributed along the longitudinal length and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light at proximal end, and (ii) change a characteristic of the reflected light signal based on a condition experienced by the optical fiber along the curved distal tip.
  • the elongate probe is configured for advancement along a vasculature of the patient body such that the elongate probe experiences fluctuations due to fluctuating movement of patient body tissue, and the fluctuations define the condition experienced by the optical fiber along the curved distal tip.
  • the elongate probe is configured for insertion within a lumen of a vascular catheter, and the curved distal tip includes a flexibility in bending such that, upon disposition of the curved distal tip within the lumen, a radius of curvature of the curved distal tip is increased.
  • the increase in the radius of curvature defines a bending strain along the curved distal tip, and the bending strain defines the condition experienced by the optical fiber along the curved distal tip.
  • the elongate probe includes a guidewire.
  • the elongate probe includes a number of electrical conductors extending along the elongate probe from the proximal end to the distal end.
  • the elongate probe includes a tip electrode at the distal end, where the tip electrode is coupled with at least one of the number of electrical conductors, and where the tip electrode is configured to obtain an ECG signal from the patient body.
  • the elongate probe includes a number of band electrodes disposed along the elongate probe, where each band electrode is coupled with at least one of the number of electrical conductors, and where the band electrodes are configured to obtain an electrical impedance between two or more band electrodes.
  • a medical system that includes a medical device.
  • the medical device includes an elongate probe configured for insertion into a patient body, where the elongate probe defines a proximal end and a curved distal tip at a distal end.
  • An optical fiber extends along the elongate probe from the proximal end to the distal end, where the optical fiber includes one or more core fibers extending along a longitudinal length of the optical fiber.
  • Each of the one or more core fibers includes a plurality of sensors distributed along the longitudinal length and each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light at proximal end, and (ii) change a characteristic of the reflected light signal based on condition experienced by the optical fiber.
  • the system further includes a console operatively coupled with the medical device at the proximal end, where the console includes one or more processors, and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations of the system.
  • the operations include determining a physical state of the curved distal tip, where determining the physical state includes: (i) providing an incident light signal to the optical fiber; (ii) receiving reflected light signals of different spectral widths of the incident light by one or more of the plurality of sensors along the curved distal tip; and (iii) processing the reflected light signals associated with the one or more core fibers to determine the physical state of the curved distal tip.
  • the physical state includes fluctuations along the curved distal tip, the fluctuations caused by fluctuating tissue movement within the patient body and in some embodiments, the fluctuating tissue movement is caused by a heartbeat.
  • the physical state includes a bending strain along the curved distal tip and in some embodiments, the bending strain along the curved distal tip is caused by disposition of the curved distal tip within a lumen of a vascular catheter.
  • the elongate probe includes a number of electrical conductors extending along the elongate probe from the proximal end to the distal end, and the operations of the system include receiving an electrical signal from one or more of the electrical conductors.
  • the elongate probe includes a tip electrode at the distal end, where the tip electrode is coupled with at least one of the number of electrical conductors, and where the electrical signal includes an ECG signal.
  • the elongate probe includes a number of band electrodes disposed along the elongate probe, where each band electrode is coupled with at least one of the number of electrical conductors, and where the electrical signal includes an impedance between two or more of the number of band electrodes.
  • the method includes providing a guidewire, where the guidewire includes an optical fiber extending along the guidewire, and where the optical fiber is operatively coupled with a console, the guidewire further includes a number of electrical conductors extending along the guidewire, where the electrical conductors are operatively coupled with the console.
  • the method further includes (i) advancing the guidewire along a vascular pathway of the patient body and (ii) determining a position of the guidewire within the vascular pathway based on one or more of a first optical signal received by the console from the guidewire or a first electrical signal received by the console from the guidewire.
  • the method further includes (i) advancing the catheter along the guidewire, where the guidewire is disposed within a lumen of the catheter and (ii) determining a location of the catheter with respect to the guidewire based on one or more of a second optical signal or a second electrical signal.
  • the optical fiber includes one or more core fibers extending along a longitudinal length of the optical fiber, where each of the one or more core fibers includes a plurality of sensors distributed along the longitudinal length, and where each sensor of the plurality of sensors is configured to (i) reflect a light signal of a different spectral width based on received incident light at proximal end, and (ii) change a characteristic of the reflected light signal based on condition experienced by the optical fiber.
  • the first optical signal includes reflected light signals of different spectral widths from one or more of the plurality of sensors based on received incident light at the proximal end, where the different spectral widths are defined by a fluctuation of the optical fiber, and where the fluctuation is caused by fluctuating tissue movement adjacent the vascular pathway.
  • the guidewire includes a curved distal tip and the second optical signal includes reflected light signals of different spectral widths from one or more of the plurality of sensors disposed along the curved distal tip based on received incident light at the proximal end, where the different spectral widths are defined by a bending strain along the curved distal tip, and where the bending strain is caused by advancing the catheter along the curved distal tip.
  • the guidewire includes a tip electrode at the distal end, where the tip electrode is coupled with at least one of the number of electrical conductors.
  • the first electrical signal includes an ECG signal obtained by the tip electrode.
  • the guidewire includes a plurality of band electrodes disposed along the guidewire, where each band electrode is coupled with at least one of the number of electrical conductors.
  • the first electrical signal is defined by an electrical impedance between two or more band electrodes, where the electrical impedance is defined by a change in an annular fluid pathway extending along the two or more band electrodes, where the change in the annual fluid pathway is caused by advancing the guidewire between two portions of the vascular pathway, and where the two portions have different cross-sectional areas.
  • the guidewire includes a plurality of band electrodes disposed along the guidewire, where each band electrode is coupled with at least one of the number of electrical conductors.
  • the second electrical signal is defined by an electrical impedance between two or more band electrodes, where the electrical impedance is defined by a change in an annular fluid pathway extending along the two or more band electrodes, and where the change in the annual fluid pathway is caused by advancing the catheter over the two or more band electrodes.
  • FIG. 1 is an illustrative embodiment of a medical device placement system including a medical device with fiber optic and electrical capabilities, in accordance with some embodiments;
  • FIG. 2 is an exemplary embodiment of a structure of the elongate probe of FIG. 1, in accordance with some embodiments;
  • FIG. 3 A illustrates an embodiment of the elongate probe of FIG. 1, in accordance with some embodiments
  • FIG. 3B is a cross sectional view of the elongate probe of FIG. 3 A, in accordance with some embodiments.
  • FIGS. 4A-4B are flowcharts of methods of operations conducted by the medical device system of FIG. 1 to achieve optical three-dimensional shape sensing, in accordance with some embodiments;
  • FIG. 5 illustrates an exemplary embodiment of the medical instrument placement system 100 of FIG. 1 during operation and insertion of the elongate probe within a patient, in accordance with some embodiments;
  • FIG. 6A illustrates an impedance between two band electrodes of distal portion of the elongate probe of FIG. 5 disposed within a first blood vessel of the patient, in accordance with some embodiments;
  • FIG. 6B illustrates an impedance between the two band electrodes of distal portion a distal portion disposed within a second blood vessel of the patient, in accordance with some embodiments
  • FIG. 6C illustrates an impedance between the two band electrodes of distal portion a distal portion disposed within a lumen of the catheter of FIG. 5, in accordance with some embodiments
  • FIG. 7A illustrates a curved distal tip of the elongate probe of FIG. 5 disposed outside of the lumen of the catheter of FIG. 5, in accordance with some embodiments.
  • FIG. 7B illustrates the curved distal tip of the elongate probe disposed within the lumen of the catheter, in accordance with some embodiments.
  • proximal portion or a “proximal end portion” of, for example, a probe disclosed herein includes a portion of the probe intended to be near a clinician when the probe is used on a patient.
  • proximal length of, for example, the probe includes a length of the probe intended to be near the clinician when the probe is used on the patient.
  • proximal end of, for example, the probe includes an end of the probe intended to be near the clinician when the probe is used on the patient.
  • the proximal portion, the proximal end portion, or the proximal length of the probe can include the proximal end of the probe; however, the proximal portion, the proximal end portion, or the proximal length of the probe need not include the proximal end of the probe. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the probe is not a terminal portion or terminal length of the probe.
  • a “distal portion” or a “distal end portion” of, for example, a probe disclosed herein includes a portion of the probe intended to be near or in a patient when the probe is used on the patient.
  • a “distal length” of, for example, the probe includes a length of the probe intended to be near or in the patient when the probe is used on the patient.
  • a “distal end” of, for example, the probe includes an end of the probe intended to be near or in the patient when the probe is used on the patient.
  • the distal portion, the distal end portion, or the distal length of the probe can include the distal end of the probe; however, the distal portion, the distal end portion, or the distal length of the probe need not include the distal end of the probe. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the probe is not a terminal portion or terminal length of the probe.
  • logic may be representative of hardware, firmware or software that is configured to perform one or more functions.
  • logic may refer to or include circuitry having data processing and/or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit (ASIC), etc.), a semiconductor memory, or combinatorial elements.
  • a hardware processor e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit (ASIC), etc.
  • ASIC application specific integrated circuit
  • logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library/dynamic link library (dll), or even one or more instructions.
  • API Application Programming Interface
  • subroutine(s) subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library/dynamic link library (dll), or even one or more instructions.
  • This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals).
  • non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random-access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device.
  • volatile memory e.g., any type of random-access memory “RAM”
  • persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device.
  • the logic may be stored in persistent storage.
  • phrases “connected to,” “coupled to,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction.
  • Two components may be coupled to each other even though they are not in direct contact with each other.
  • two components may be coupled to each other through an intermediate component.
  • Any methods disclosed herein comprise one or more steps or actions for performing the described method.
  • the method steps and/or actions may be interchanged with one another.
  • the order and/or use of specific steps and/or actions may be modified.
  • FIG. 1 illustrates an embodiment of a medical instrument placement system including a medical instrument.
  • the medical instrument placement system (system) 100 generally includes a console 110 and an elongate probe 120 communicatively coupled with the console 110.
  • the elongate probe 120 defines a distal end 122 and includes a console connector 133 at a proximal end 124.
  • the elongate probe 120 includes an optical fiber 135 including multiple core fibers extending along a length of the elongate probe 120 as further described below.
  • the console connector 133 enables the elongate probe 120 to be operably connected to the console 110 via an interconnect 145 including one or more optical fibers 147 (hereinafter, “optical fiber(s)”).
  • the elongate probe 120 further includes a number of electrical conductors 125 (e.g., wires) that extend along the elongate probe 120.
  • the electrical conductors 125 may define an electrical coupling of a tip electrode 123 at the distal end 122 to a single optical/electric connector 146 (or dual connectors) at the proximal end 124.
  • the connector 146 is configured to engage (mate) with the console connector 133 to allow for the propagation of light between the console 110 and the elongate probe 120 as well as the propagation of electrical signals from the elongate probe 120 to the console 110.
  • the tip electrode 123 may be configured to obtain an electrical signal from the patient (e.g., an ECG signal).
  • the elongate probe 120 may include a number of band electrodes 127 disposed along an outer surface of the elongate probe 120 and the electrical conductors 125 may define an electrical coupling of the band electrodes 127 to the optical/electric connector 146.
  • a distal portion 129 of the elongate probe 120 is defined that includes the curved distal tip 128, the tip electrode 123, and the band electrodes 127.
  • the elongate probe 120 includes a curved distal tip 128.
  • the curved distal tip 128 may define a curved shape in a free state.
  • the curved distal tip 128 may include a bending flexibility to allow the curved shape to straighten, i.e., become less curved during use, such as when the curved distal tip 128 is disposed within a lumen of a catheter, for example.
  • the elongate probe 120 may be configured to perform any of a variety of medical procedures. As such, the elongate probe 120 may be a component of or employed with a variety of medical instruments/devices. In some implementations, the elongate probe 120 may take the form of a guidewire or a stylet, for example. The elongate probe 120 may be formed of a metal, a plastic or a combination thereof. The elongate probe 120 includes a lumen 121 extending therealong having an optical fiber 135 disposed therein.
  • the elongate probe 120 may be employed with a vascular catheter.
  • Other exemplary implementations include drainage catheters, surgery devices, stent insertion and/or removal devices, biopsy devices, endoscopes, and kidney stone removal devices.
  • the elongate probe 120 may be employed with, or the elongate probe 120 may be a component of, any medical device that is inserted into a patient.
  • the console 110 includes one or more processors 160, a memory 165, a display 170, and optical logic 180, although it is appreciated that the console 110 can take one of a variety of forms and may include additional components (e.g., power supplies, ports, interfaces, etc.) that are not directed to aspects of the disclosure.
  • An illustrative example of the console 110 is illustrated in U.S. Publication No. 2019/0237902, the entire contents of which are incorporated by reference herein.
  • the one or more processors 160, with access to memory 165 are included to control functionality of the console 110 during operation.
  • the display 170 may be a liquid crystal diode (LCD) display integrated into the console 110 and employed as a user interface to display information to the clinician, especially during an instrument placement procedure.
  • the display 170 may be separate from the console 110.
  • a user interface is configured to provide user control of the console 110.
  • the content depicted by display 170 may change according to which mode the elongate probe 120 is configured to operate: optical, TLS, ECG, or another modality.
  • TLS mode the content rendered by the display 170 may constitute a two-dimensional or three-dimensional representation of the physical state (e.g., length, shape, form, and/or orientation) of the elongate probe 120 computed from characteristics of reflected light signals 150 returned to the console 110.
  • the reflected light signals 150 constitute light of a specific spectral width of broadband incident light 155 reflected back to the console 110.
  • the reflected light signals 150 may pertain to various discrete portions (e.g., specific spectral widths) of broadband incident light 155 transmitted from and sourced by the optical logic 180, as described below.
  • an activation control 126 included on the elongate probe 120, may be used to set the elongate probe 120 into a desired operating mode and selectively alter operability of the display 170 by the clinician to assist in medical device placement.
  • the display 170 of the console 110 can be employed for optical modality-based guidance during probe advancement through the vasculature or TLS modality to determine the physical state (e.g., length, form, shape, orientation, etc.) of the elongate probe 120.
  • information from multiple modes such as optical, TLS or ECG for example, may be displayed concurrently (e.g., at least partially overlapping in time).
  • the optical logic 180 is configured to support operability of the elongate probe 120 and enable the return of information to the console 110, which may be used to determine the physical state associated with the elongate probe 120.
  • Electrical signals such as ECG signaling, may be processed via an electrical signaling logic 181 that supports receipt and processing of the received electrical signals from the elongate probe 120, (e.g., ports, analog-to-digital conversion logic, etc.).
  • Electrical signals, such as a pacemaker signal, for example, may also be defined and provided by the electrical signaling logic 181.
  • the physical state of the elongate probe 120 may be based on changes in characteristics of the reflected light signals 150 received at the console 110 from the elongate probe 120.
  • the characteristics may include shifts in wavelength caused by strain along certain regions of the core fibers integrated within the optical fiber 135 positioned within or operating as the elongate probe 120, as shown below.
  • core fiber(s) 137 may collectively be referred to as core fiber(s) 137.
  • embodiments discussed herein will refer to an optical fiber 135. From information associated with the reflected light signals 150, the console 110 may determine (through computation or extrapolation of the wavelength shifts) the physical state of the elongate probe 120.
  • the optical logic 180 may include a light source 182 and an optical receiver 184.
  • the light source 182 is configured to transmit the incident light 155 (e.g., broadband) for propagation over the optical fiber(s) 147 included in the interconnect 145, which are optically connected to the optical fiber 135 within the elongate probe 120.
  • the light source 182 is a tunable swept laser, although other suitable light sources can also be employed in addition to a laser, including semi-coherent light sources, LED light sources, etc.
  • the optical receiver 184 is configured to: (i) receive returned optical signals, namely reflected light signals 150 received from optical fiber-based reflective gratings (sensors) fabricated within each core fiber of the optical fiber 135 deployed within the elongate probe 120, and (ii) translate the reflected light signals 150 into reflection data (from a data repository 190), namely data in the form of electrical signals representative of the reflected light signals including wavelength shifts caused by strain.
  • the reflected light signals 150 associated with different spectral widths may include reflected light signals 151 provided from sensors positioned in the center core fiber (reference) of the optical fiber 135 and reflected light signals 152 provided from sensors positioned in the periphery core fibers of the optical fiber 135, as described below.
  • optical receiver 184 may be implemented as a photodetector, such as a positive-intrinsic-negative “PIN” photodiode, avalanche photodiode, or the like.
  • Both the light source 182 and the optical receiver 184 are operably connected to the one or more processors 160, which governs their operation. Also, the optical receiver 184 is operably coupled to provide the reflection data (from the data repository 190) to the memory 165 for storage and processing by reflection data classification logic 192.
  • the reflection data classification logic 192 may be configured to: (i) identify which core fibers pertain to which of the received reflection data (from the data repository 190) and (ii) segregate the reflection data stored within the data repository 190 provided from reflected light signals 150 pertaining to similar regions of the elongate probe 120 or spectral widths into analysis groups. The reflection data for each analysis group is made available to state sensing logic 194 for analytics.
  • the state sensing logic 194 is configured to compare wavelength shifts measured by sensors deployed in each periphery core fiber at the same measurement region of the elongate probe 120 (or same spectral width) to the wavelength shift at a center core fiber of the optical fiber 135 positioned along central axis and operating as a neutral axis of bending. From these analytics, the state sensing logic 194 may determine the shape the core fibers have taken in three-dimensional space and may further determine the current physical state of the elongate probe 120 in three-dimensional space for rendering on the display 170.
  • the state sensing logic 194 may generate a rendering of the current physical state of the elongate probe 120, based on heuristics or run-time analytics.
  • the state sensing logic 194 may be configured in accordance with machine-learning techniques to access the data repository 190 with prestored data (e.g., images, etc.) pertaining to different regions of the elongate probe 120 in which reflected light from core fibers have previously experienced similar or identical wavelength shifts. From the pre-stored data, the current physical state of the elongate probe 120 may be rendered.
  • the state sensing logic 194 may be configured to determine, during run-time, changes in the physical state of each region of the optical fiber 135 based on at least: (i) resultant wavelength shifts experienced by different core fibers within the optical fiber 135, and (ii) the relationship of these wavelength shifts generated by sensors positioned along different periphery core fibers at the same cross- sectional region of the optical fiber 135 to the wavelength shift generated by a sensor of the center core fiber at the same cross-sectional region.
  • the console 110 may further include optional electrical signaling logic 181 configured to receive one or more electrical signals from the elongate probe 120.
  • the elongate probe 120 is configured to support both optical connectivity as well as electrical connectivity.
  • the electrical signaling logic 181 receives the electrical signals (e.g., ECG signals) from the elongate probe 120 via the conductive medium.
  • the electrical signal analytic logic 196 may be configured to extract an ECG signal from the electrical signals.
  • the electrical signal analytic logic 196 may further cause an ECG waveform to be portrayed on the display 170.
  • wavelength shifts as measured by sensors along each of the core fibers within the optical fiber 135 may be based on physical states or conditions of the probe 120 other than or in addition to longitudinal strain experienced by the elongate probe 120.
  • Alternative or additional physical states may include one or more of torsional strain, temperature, motion, fluctuations, oscillations, pressure, or fluid flow adjacent the elongate probe.
  • the console 110 includes a fluctuation logic 195 that is configured to analyze at least a subset of the wavelength shifts measured by sensors deployed in each of the core fibers 137.
  • the fluctuation logic 195 is configured to analyze wavelength shifts measured by sensors of core fibers 137, where such corresponds to an analysis of the fluctuation of the distal end 122 of the elongate probe 120 or any other section of the elongate probe 120 (or “tip fluctuation analysis”).
  • the fluctuation logic 195 analyzes the wavelength shifts measured by sensors at a distal end of the core fibers 137.
  • a “tip fluctuation analysis” may include at least a correlation of detected movements of the distal portion 129 of the elongate probe 120 with experiential knowledge comprising previously detected movements (fluctuations), and optionally, other current measurements such as ECG signals.
  • the experiential knowledge may include previously detected movements in various locations within the vasculature (e.g., SVC, Inferior Vena Cava (IVC), right atrium, azygos vein, other blood vessels such as arteries and veins) under normal, healthy conditions and in the presence of defects (e.g., vessel constriction, vasospasm, vessel occlusion, etc.).
  • the tip fluctuation analysis may result in a confirmation of a location of the distal portion 129 and/or detection of a defect affecting a blood vessel.
  • the fluctuation logic 195 need not perform the same analyses as the shape sensing logic 194.
  • the shape sensing logic 194 determines a 3D shape of the elongate probe 120 by comparing wavelength shifts in outer core fibers of a multi-core optical fiber to a center, reference core fiber.
  • the fluctuation logic 195 may instead correlate the wavelength shifts to previously measured wavelength shifts and optionally other current measurements without distinguishing between wavelength shifts of outer core fibers and a center, reference core fiber as the tip fluctuation analysis need not consider direction or shape within a 3D space.
  • the analysis of the fluctuation logic 195 may utilize electrical signals (e.g., ECG signals) measured by the electrical signaling logic 181.
  • the fluctuation logic 195 may compare the movements of a subsection of the elongate probe 120 (e.g., the distal tip) with electrical signals indicating impulses of the heart (e.g., the heartbeat). Such a comparison may reveal whether the distal tip is within the SVC or the right atrium based on how closely the movements correspond to a rhythmic heartbeat.
  • a display and/or alert may be generated based on the fluctuation analysis.
  • the fluctuation logic 195 may generate a graphic illustrating the detected fluctuation compared to previously detected tip fluctuations and/or the anatomical movements of the patient body such as rhythmic pulses of the heart and/or expanding and contracting of the lungs.
  • a graphic may include a dynamic visualization of the present medical device moving in accordance with the detected fluctuations adjacent to a secondary medical device moving in accordance with previously detected tip fluctuations.
  • the location of a subsection of the medical device may be obtained from the shape sensing logic 194 and the dynamic visualization may be location-specific (e.g., such that the previously detected fluctuations illustrate expected fluctuations for the current location of the subsection).
  • the dynamic visualization may illustrate a comparison of the dynamic movements of the subsection to one or more subsections moving in accordance with previously detected fluctuations of one or more defects affecting the blood vessel.
  • the fluctuation logic 195 may determine whether movements of one or more subsections of the elongate probe 120 indicate a location of a particular subsection of the elongate probe 120 or a defect affecting a blood vessel, based on heuristics or run-time analytics.
  • the fluctuation logic 195 may be configured in accordance with machine-learning techniques to access a data store (library) with pre-stored data (e.g., experiential knowledge of previously detected tip fluctuation data, etc.) pertaining to different regions (subsections) of the elongate probe 120.
  • such an embodiment may include processing of a machine-learning model trained using the experiential knowledge, where the detected fluctuations serve as input to the trained model and processing of the trained model results in a determination as to how closely the detected fluctuations correlate to one or more locations within the vasculature of the patient and/or one or more defects affecting a blood vessel.
  • the fluctuation logic 195 may be configured to determine, during run-time, whether movements of one or more subsections of the elongate probe 120 indicate a location of a particular subsection of the elongate probe 120 or a defect affecting a blood vessel, based on at least (i) resultant wavelength shifts experienced by the core fibers 137 within the one or more subsections, and (ii) the correlation of these wavelength shifts generated by sensors positioned along different core fibers at the same cross-sectional region of the elongate probe 120 to previously detected wavelength shifts generated by corresponding sensors in a core fiber at the same cross-sectional region. It is contemplated that other processes and procedures may be performed to utilize the wavelength shifts as measured by sensors along each of the core fibers 137 to render appropriate movements in the distal portion 129 of the elongate probe 120.
  • FIG. 2 an exemplary embodiment of a structure of a section of the elongate probe 120 of FIG. 1 is shown in accordance with some embodiments.
  • the core fibers 137I-137M may be collectively referred to as “the core fibers 137.”
  • the section 200 is subdivided into a plurality of cross-sectional regions 220I-220N, where each cross-sectional region 220I-220N corresponds to reflective gratings 210U-210I4...210NI-210N4.
  • Some or all of the cross-sectional regions 220I...220N may be static (e.g., prescribed length) or may be dynamic (e.g., vary in size among the regions 220i...220N).
  • a first core fiber 137i is positioned substantially along a center (neutral) axis 230 while core fiber 1372 may be oriented within the cladding of the optical fiber 135, from a cross-sectional, front-facing perspective, to be position on “top” the first core fiber 137i.
  • the core fibers 1373 and 1374 may be positioned “bottom left” and “bottom right” of the first core fiber 137i.
  • FIGS. 3A-4B provides illustrations of such.
  • each of the reflective gratings 210I-210N reflects light for a different spectral width.
  • each of the gratings 210n-210Ni (l ⁇ i ⁇ M) is associated with a different, specific spectral width, which would be represented by different center frequencies of /X . . . /N, where neighboring spectral widths reflected by neighboring gratings are non-overlapping according to one embodiment of the disclosure.
  • the gratings 210x2-210N2 and 210x3- 210N3 are configured to reflect incoming light at same (or substantially similar) center frequency.
  • the reflected light returns information that allows for a determination of the physical state of the core fibers 137 (and the elongate probe 120) based on wavelength shifts measured from the returned, reflected light.
  • strain e.g., compression or tension
  • applied to the optical fiber 135 results in wavelength shifts associated with the returned, reflected light.
  • the core fibers 137x— 1374 experience different types and degree of strain based on angular path changes as the elongate probe 120 advances in the patient. Specifically, the core fibers 137x- 137 4 may experience a strain when the curved distal tip 128 becomes less curved.
  • the fourth core fiber 1374 (see FIG. 3A) of the optical fiber 135 with the shortest radius during movement (e.g., core fiber closest to a direction of angular change) would exhibit compression (e.g., forces to shorten length).
  • the third core fiber 1373 with the longest radius during movement e.g., core fiber furthest from the direction of angular change
  • tension e.g., forces to increase length
  • the reflected light from reflective gratings 210N2 and 210N3 associated with the core fiber 1372 and 1373 will exhibit different changes in wavelength.
  • the differences in wavelength shift of the reflected light signals 150 can be used to extrapolate the physical configuration of the elongate probe 120 by determining the degrees of wavelength change caused by compression/tension for each of the periphery fibers (e.g., the second core fiber 1372 and the third core fiber 1373) in comparison to the wavelength of the reference core fiber (e.g., first core fiber 137x) located along the neutral axis 230 of the optical fiber 135. These degrees of wavelength change may be used to extrapolate the physical state of the elongate probe 120.
  • the optical fiber 135 may include sensors 215, where wavelength shifts as measured by the sensors 215 along the optical fiber 135 may be based on physical states or conditions of the probe 120 that include one or more than a temperature experienced by the elongate probe 120, a pressure exerted on the elongate probe 120, or a fluid flow (e.g., blood flow) adjacent the elongate probe 120.
  • the sensors 215 may located along any of the core fibers 137 or along additional core fibers (not shown).
  • the state sensing logic 194 may be configured to determine one or more of the temperature, the pressure, or the fluid flow.
  • the elongate probe 120 of FIG. 1 supporting both an optical and electrical signaling is shown in accordance with some embodiments.
  • optical fiber 135 is illustrated within four (4) core fibers 1371-1374, a greater number of core fibers 137i— 137M (M>4) may be deployed to provide a more detailed three-dimensional sensing of the physical state (e.g., shape, etc.) of the optical fiber 135 and the elongate probe 120 deploying the optical fiber 135.
  • M the number of core fibers 137i— 137M (M>4) may be deployed to provide a more detailed three-dimensional sensing of the physical state (e.g., shape, etc.) of the optical fiber 135 and the elongate probe 120 deploying the optical fiber 135.
  • the optical fiber 135 is encapsulated within a concentric tubing 310 (e.g., braided tubing as shown) positioned over a low coefficient of friction layer 335.
  • the concentric tubing 310 may in some embodiments, feature a “mesh” construction, in which the spacing between the intersecting elements may be selected based on the degree of rigidity/flexibility desired for the elongate probe 120, as a greater spacing may provide a lesser rigidity, and thereby, a more flexible elongate probe 120.
  • the core fibers 1371-1374 include (i) a central core fiber 137i and (ii) a plurality of periphery core fibers 1372-1374, which are maintained within lumens 3201-3204 formed in the cladding 300.
  • one or more of the lumen 3201-3204 may be configured with a diameter sized to be greater than the diameter of the core fibers 1371-1374.
  • the wavelength changes to the incident light are caused by angular deviations in the optical fiber 135 thereby reducing influence of compression and tension forces being applied to the walls of the lumens 320i- 320M, not the core fibers 1371-137M themselves.
  • the core fibers 1371-1374 may include central core fiber 137i residing within a first lumen 320i formed along the first neutral axis 230 and a plurality of core fibers 1372-1374 residing within lumens 3202-3204 each formed within different areas of the cladding 300 radiating from the first neutral axis 230.
  • the core3fibers 1372-1374, exclusive of the central core fiber 137i may be positioned at different areas within a cross-sectional area 305 of the cladding 300 to provide sufficient separation to enable three-dimensional sensing of the optical fiber 135 based on changes in wavelength of incident light propagating through the core fibers 1372-1374 and reflected back to the console for analysis.
  • the core fibers 1372-1374 may be positioned substantially equidistant from each other as measured along a perimeter of the cladding 300, such as at “top” (12 o’clock), “bottom-left” (8 o’clock) and “bottom-right” (4 o’clock) locations as shown.
  • the core fibers 1372-1374 may be positioned within different segments of the cross-sectional area 305.
  • the central core fiber 137i may be located at or near a center of the polygon shape, while the remaining core fibers 1372-137M may be located proximate to angles between intersecting sides of the polygon shape.
  • the braided tubing 310 provides mechanical integrity to the multi-core optical fiber 135
  • the cladding 300 and the braided tubing 310 which is positioned concentrically surrounding a circumference of the cladding 300, are contained within the same insulating layer 350.
  • the insulating layer 350 may be a sheath or conduit made of protective, insulating (e.g., non-conductive) material that encapsulates both the cladding 300 and the braided tubing 310, as shown.
  • the elongate probe 120 includes a number of electrical conductors 125 (e.g., wires) extending along the length of the elongate probe 120.
  • the electrical conductors 125 may be embedded within the cladding 300 of the optical fiber 135 as shown.
  • the electrical conductors 125 may be enclosed within the insulating layer 350 in other ways, such as between the friction layer 335 and the braided tubing 310, between the braided tubing 310 and the insulating layer 350 friction, or between the friction layer 335 and the optical fiber 135, for example.
  • the electrical conductors 125 may include the braided tubing 310.
  • the electrical conductors 125 may be disposed along an outer surface of the elongate probe 120.
  • the first micro-lumen is coaxial with the central axis of the probe.
  • the first micro-lumen is configured to retain a center core fiber.
  • Two or more micro-lumen, other than the first micro-lumen, are positioned at different locations circumferentially spaced along the circumferential edge of the probe.
  • two or more of the second plurality of micro-lumens may be positioned at different quadrants along the circumference edge of the probe.
  • each core fiber includes a plurality of sensors spatially distributed along its length between at least the proximal and distal ends of the probe.
  • This array of sensors is distributed to position sensors at different regions of the core fiber to enable distributed measurements of strain throughout the entire length or a selected portion of the probe.
  • These distributed measurements may be conveyed through reflected light of different spectral widths (e.g., specific wavelength or specific wavelength ranges) that undergoes certain wavelength shifts based on the type and degree of strain, including oscillations of the strain.
  • broadband incident light is supplied to propagate through a particular core fiber (block 400).
  • a sensor of a distributed array of sensors measuring strain on a particular core fiber light of a prescribed spectral width associated with the first sensor is to be reflected back to an optical receiver within a console (blocks 405-410).
  • the sensor alters characteristics of the reflected light signal to identify the type and degree of strain on the particular core fiber as measured by the first sensor (blocks 415-420).
  • the alteration in characteristics of the reflected light signal may signify a change (shift) in the wavelength of the reflected light signal from the wavelength of the incident light signal associated with the prescribed spectral width.
  • the sensor returns the reflected light signal over the core fiber and the remaining spectrum of the incident light continues propagation through the core fiber toward a distal end of the probe (blocks 425-430).
  • the remaining spectrum of the incident light may encounter other sensors of the distributed array of sensors, where each of these sensors would operate as set forth in blocks 405-430 until the last sensor of the distributed array of sensors returns the reflected light signal associated with its assigned spectral width and the remaining spectrum is discharged as illumination.
  • the optical receiver receives reflected light signals from the distributed arrays of sensors located on the center core fiber and the outer core fibers and translates the reflected light signals into reflection data, namely electrical signals representative of the reflected light signals including wavelength shifts caused by strain (blocks 450-455).
  • the reflection data classification logic is configured to identify which core fibers pertain to which reflection data and segregate reflection data provided from reflected light signals pertaining to a particular measurement region (or similar spectral width) into analysis groups (block 460-465).
  • Each analysis group of reflection data is provided to sensing logic for analytics (block 470).
  • the sensing logic compares wavelength shifts at each outer core fiber with the wavelength shift at the center core fiber positioned along central axis and operating as a neutral axis of bending (block 475). From this analytics, on all analytic groups (e.g., reflected light signals from sensors in all or most of the core fibers), the sensing logic may determine the shape the core fibers have taken in three-dimensional space, from which the sensing logic can determine the current physical state of the probe in three-dimensional space (blocks 480-485).
  • FIG. 5 illustrates an exemplary embodiment of the medical instrument placement system 100 of FIG. 1 during operation and insertion of a catheter into a patient 505.
  • the elongate probe 120 is advanced to a desired position within the patient vasculature so that a distal end 122 of the elongate probe 120 is proximate the patient’s heart, such as in the lower one-third (1/3) portion of the Superior Vena Cava (“SVC”) for example.
  • SVC Superior Vena Cava
  • the elongate probe 120 may pass through different portions of the vasculature.
  • the elongate probe 120 passes through the brachial vein 510 and the subclavian vein 511 on its way to the superior vena cava 512.
  • the distal portion 129 passed through (i.e., for a period of time resided within) the brachial vein 510 and the subclavian vein 511 on its way to the superior vena cava 512.
  • the catheter 530 may be advanced along the elongate probe 120. In the illustrated example, the catheter 530 is partially advanced along elongate probe 120 on its way toward the superior vena cava 512.
  • the fluctuation logic 195 of FIG. 1 may be configured to analyze at least a subset of the wavelength shifts measured by sensors deployed in each of the core fibers 137.
  • each core fiber 137 of the elongate probe 120 may be comprised of a plurality of subsections with each subsection including a set of sensors, where the sensors of each subsection may receive an incident light signal and alter the characteristics of the reflected light signal in accordance with detected axial strain.
  • the fluctuation logic 195 may then analyze the wavelength shifts corresponding to the reflected light signal received from a subsection of the elongate probe 120.
  • FIG. 5 shows heartbeat fluctuations 517 generated by the heart 507 and breathing fluctuations 518 generated by the lungs 508.
  • Each of the heartbeat fluctuations 517 and breathing fluctuations 518 may cause portions of the elongate probe 120 to fluctuate when the elongate probe 120 is disposed within the vasculature.
  • one portion of the elongate probe 120 may be located within the vasculature so as to fluctuate in accordance with the heartbeat fluctuations 517.
  • another portion of the elongate probe 120 may be located within the vasculature so as to fluctuate in accordance with the breathing fluctuations 518.
  • the fluctuation logic 195 may be configured to determine the location of the elongate probe 120 (or more specifically the location of various portions of the elongate probe 120) within the vasculature.
  • the fluctuation logic 195 may determine the location of the distal portion 129 of the elongate probe 120.
  • the distal portion 129 may fluctuate in accordance with the heartbeat fluctuations 517 when the distal portion 129 is disposed within the superior vena cava 512.
  • the fluctuation logic 195 may detect heartbeat fluctuations 517 along the distal portion 129 and thereby determine when the distal portion 129 is disposed within the superior vena cava 512.
  • the fluctuation logic 195 may notify the user that the distal portion 129 is disposed within the superior vena cava 512.
  • the electrical signal analytic logic 196 may be configured to determine the position of the tip electrode 123 within the vasculature. More specifically, the electrical signal analytic logic 196 may utilize an ECG signal obtained by the tip electrode 123 to determine a location of the tip electrode 123 within the superior vena cava 512, such as within the lower one-third (1/3) portion of the superior vena cava 512, for example. Thus, ECG signal obtained by the tip electrode 123 serves as an aide in confirming proper placement of elongate probe 120, and thereafter the catheter 530.
  • FIGS. 6A-6B illustrate the sensing of impedance between two band electrodes 627A, 627B under various conditions.
  • FIG. 6A illustrates the elongate probe 120 within the brachial vein 510, where the brachial vein 510 has a smaller cross-sectional area than the subclavian vein 511 or the superior vena cava 512.
  • Blood 601 flows along the band electrodes 627A, 627B through an annular flow path 603 defined the brachial vein 510 having the elongate probe 120 disposed therein.
  • a first electrical impedance 606 may generally be defined by (i) the conductivity of the blood 601, (ii) the distance between the band electrodes 627A, 627B, and (iii) a cross-sectional area of the annular flow path 603.
  • FIG. 6B illustrates the elongate probe 120 within the superior vena cava 512 defining an annular flow path 604 having a greater cross sectional area than the annular flow path 603 of the brachial vein 510.
  • a second electrical impedance 607 may generally be defined by (i) the conductivity of the blood 601, the distance between the band electrodes 627A, 627B, and a cross-sectional area of the annular flow path 603.
  • the second electrical impedance 607 may be less than the first impedance 606 because the cross-sectional area of the annular flow path 604 is greater than the cross- sectional area of the annular flow path 603.
  • FIG. 6C illustrates the elongate probe 120 along with the catheter 530 disposed within the superior vena cava 512.
  • the catheter 530 is advanced over the band electrodes 627A, 627B to define an annular flow path 605 between the elongate probe 120 and the catheter wall 531.
  • a third electrical impedance 608 may generally be defined by (i) the conductivity of the fluid 602 with the catheter 530, the distance between the band electrodes 627 A, 627B, and a cross-sectional area of the annular flow path 605.
  • the cross sectional area of the annular flow path 605 may be less than the cross-sectional areas of the annular flow paths 603, 604.
  • the third electrical impedance 608 may be greater than the first impedance 606 and the second impedance 607 because the cross-sectional area of the annular flow path 605 is less than the cross-sectional areas of the annular flow paths 603, 604.
  • the electrical signal analytic logic 196 may utilize an impedance signal (an electrical signal related to the impedance between the band electrodes 627A, 627B) to determine a location of the elongate probe 120 within the vasculature.
  • the electrical signal analytic logic 196 may monitor the impedance signal during advancement of the elongate probe 120 along the vasculature.
  • the electrical signal analytic logic 196 may detect a change in the impedance signal when the distal portion 129 (i.e., the band electrodes 627 A, 627B) passes from the brachial vein 510 into the subclavian vein 511.
  • the electrical signal analytic logic 196 may notify the user when the distal portion 129 pass from one vein to another vein.
  • the electrical signal analytic logic 196 may notify the user when the distal portion 129 enters the superior vena cava 512.
  • the electrical signal analytic logic 196 may utilize an impedance signal to determine a location of the catheter 530 with respect to the elongate probe 120.
  • the electrical signal analytic logic 196 may monitor the impedance signal during advancement of the catheter 530 along the elongate probe 120.
  • the electrical signal analytic logic 196 may detect a change in the impedance signal when the catheter 530 is advanced over the distal portion 129 (i.e., the band electrodes 627A, 627B).
  • the electrical signal analytic logic 196 may notify the user when the catheter 530 is displaced over (i.e., covers) the distal portion 129.
  • the distal portion 129 may be located (i.e., previously positioned) at a desired location for the catheter 530 (or more specifically the distal end of the catheter 530), such as within the lower l/S” 1 portion of the superior vena cava 512.
  • the notification may also indicate that the distal end of the catheter 530 is positioned within the lower I /3 rd portion of the superior vena cava 512.
  • FIGS. 7A-7B illustrate the curved distal tip 128 in two states of bending strain.
  • FIG. 7A illustrates the curved distal tip 128 outside of the catheter lumen 532, where the curved distal tip 128 defines a first bending strain 728A along the curved distal tip 128 consistent with the curved distal tip 128 in the free state.
  • FIG. 7B illustrates the curved distal tip 128 within of the catheter lumen 532, where the curved distal tip 128 defines a second bending strain 728A along the curved distal tip 128 consistent with the curved distal tip 128 constrained within the catheter lumen 532.
  • the curved distal tip 128 less curved (i.e., defines a larger radius of curvature) when disposed within the catheter lumen 532 than when the curved distal tip 128 is disposed outside the catheter lumen 532 (FIG. 7A).
  • the state sensing logic 194 may be configured to detect the change in bending strain between the first bending strain 728A and the second bending strain 728A. As such, the state sensing logic 194 may determine that the catheter 530 covers the curved distal tip 128, i.e., distal end 730 of the catheter 530 is beyond the distal end 122 of the elongate probe 120. Furthermore, the state sensing logic 194 may be configured to notify/alert the user, during advancement of the catheter 530 along the elongate probe 120, when the distal end 730 of the catheter 530 is advanced along the curved distal tip 128.
  • the user may know that the distal end 730 of the catheter 530 is disposed adjacent the distal end of the elongate probe 120.
  • the distal portion 129 of the elongate probe 120 may be located (i.e., previously positioned) at a desired location for the catheter 530 (or more specifically the distal end of the catheter 530), such as within the lower I /3 rd portion of the superior vena cava 512.
  • the notification also indicates that the distal end of the catheter 530 is positioned within the lower l/3 rd portion of the superior vena cava 512.

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Abstract

Le suivi de dispositifs médicaux de forme allongée à l'intérieur du corps d'un patient peut être difficile. L'invention concerne des systèmes et dispositifs médicaux pour résoudre ce problème comprenant une sonde de forme allongée configurée pour une insertion chez un patient et/ou dans un cathéter. La sonde de forme allongée comprend une fibre optique et une pluralité de conducteurs électriques se prolongeant le long de la sonde de forme allongée. La sonde comprend en outre une électrode de pointe et un certain nombre d'électrodes de bande pour l'obtention d'un signal ECG et d'une bioimpédance, respectivement. La fibre optique est configurée pour une détection de forme et pour détecter une contrainte et des fluctuations de la sonde. Un système comprend la sonde, et une logique du système est configurée pour déterminer une position de la sonde le long d'un système vasculaire et déterminer en outre une position d'un cathéter par rapport à la sonde par l'intermédiaire de signaux optiques et/ou de signaux électriques.
PCT/US2023/019130 2022-04-20 2023-04-19 Systèmes de détection de fil-guide à fibre optique WO2023205257A1 (fr)

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